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出境医 / 临床实验 / Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE)

Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE)

Study Description
Brief Summary:
The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.

Condition or disease Intervention/treatment Phase
Cancer Risk Reduction Behavior Other: Patient Directed Standard of Care Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Patient Directed Standard of Care
Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.
Other: Patient Directed Standard of Care
The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.

No Intervention: Enhanced Standard of Care
Patients receive standard counseling from a genetic counselor.
Outcome Measures
Primary Outcome Measures :
  1. Completion of genetic testing from electronic health record [ Time Frame: 1 month following pre-test genetic counseling ]
    Percentage of patients who decide to receive genetic testing


Secondary Outcome Measures :
  1. Completion of genetic counseling from electronic health record [ Time Frame: 1 month after study invitation ]
    Percentage of patients who decide to receive genetic counseling

  2. Adherence to management recommendations from genetic counselor: questionnaire [ Time Frame: 8 weeks and 13 months from pre-test counseling ]
    Adherence to cancer screening and prevention recommendations given by genetic counselor


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaks English

AND

  • First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer

OR

  • First degree relative or second degree relative diagnosed with the following <50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.

OR

  • Three of more relatives on the same side of the family diagnosed with the following clusters of cancer regardless of age:

    • Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
    • Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas Cancer, Urinary tract, Brain, Small intestine
    • Melanoma, Pancreas Cancer

OR

  • Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.

Exclusion Criteria:

  • Patients with a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing related to hereditary cancer.
  • Patients unable to access the patient portal
Contacts and Locations

Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
New York University
Investigators
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Principal Investigator: Kimberly Kaphingst, PhD University of Utah
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
Completion of genetic testing from electronic health record [ Time Frame: 1 month following pre-test genetic counseling ]
Percentage of patients who decide to receive genetic testing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Completion of genetic counseling from electronic health record [ Time Frame: 1 month after study invitation ]
    Percentage of patients who decide to receive genetic counseling
  • Adherence to management recommendations from genetic counselor: questionnaire [ Time Frame: 8 weeks and 13 months from pre-test counseling ]
    Adherence to cancer screening and prevention recommendations given by genetic counselor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broadening the Reach, Impact, and Delivery of Genetic Services
Official Title  ICMJE Broadening the Reach, Impact, and Delivery of Genetic Services
Brief Summary The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.
Detailed Description

Patient Screening: A comprehensive screening algorithm will identify patients with family history data in various sections of the electronic health record (EHR) who meet current genetic testing criteria. Randomization to study arm (Enhanced Standard of Care or Patient-Directed Standard of Care) will be at the level of the primary care clinic.

Enhanced Standard of Care Patients will be offered the opportunity to schedule a pre-test genetic counseling visit. Pre-test counseling includes review of the family history, risk assessment, discussion of the purpose of genetic testing and possible outcomes, implications for insurance coverage, costs, and assessment of psychosocial needs. Patients can opt to proceed with genetic testing during this session. All test results are returned by a genetic counselor by phone or in person based on the patient preference. A copy of the results and a letter with tailored screening recommendations are returned to the primary care provider and patient via the patient portal or mail.

Patient-Directed Standard of Care The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal of the electronic health record. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU (New York University). Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone. A copy of the results and a letter with tailored screening recommendations will be provided to the patient and primary care provider via the patient portal.

All patients will be offered the option to schedule follow-up appointments in the genetics clinics.

Genetic Testing:

Genetic testing will be performed by Clinical Laboratory Improvement Act (CLIA)- certified, commercial laboratories based on standard clinical practice. Genetic testing will not be required to participate in the research questionnaires.

Research Procedures:

Two follow-up questionnaires will be sent via the patient portal following interaction with genetic counseling:

i. Questionnaire #1: For participant who chose to receive genetic testing, a questionnaire will be sent approximately 4 weeks after their genetic results are returned. Through this questionnaire investigators will assess cognitive (i.e., recall, comprehension, uncertainty, risk perceptions), affective (i.e., test-related distress, positive reactions, decision regret), communication responses (i.e., family, provider), experience with genetic counseling, and sociodemographic characteristics. For those who chose not to test, a questionnaire will be sent approximately 4 weeks after last genetic service contact. In this questionnaire investigators will assess experience with genetic counseling, reason for not testing, decision regret, risk perceptions, and sociodemographic characteristics including numeracy.

ii. Questionnaire #2: A questionnaire will be administered approximately 12 months after last genetic services contact. For those who chose to test, this questionnaire will ask about discussion of their test results with their primary care provider, family members, or others, and self-reported use of cancer screenings. For those who decide not to receive genetic testing, investigators will assess the self-reported use of cancer screenings, whether genetic testing was pursued at another time or through another source, communication with family members, and whether other relatives had received testing.

For any participants who would like to complete questionnaires by telephone, a genetic counseling assistant or research coordinator will administer the questionnaire. Calls will be digitally recorded to allow for analysis of comprehension. Each questionnaire will take about 15 minutes to complete. Participants may also complete the questionnaires by mail if they choose.

In addition to the questionnaires, investigators will examine screenings, care or health procedures related to genetic services recorded in the electronic health record to determine if an impact is made because of participation in genetic services.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Cancer
  • Risk Reduction Behavior
Intervention  ICMJE Other: Patient Directed Standard of Care
The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.
Study Arms  ICMJE
  • Active Comparator: Patient Directed Standard of Care
    Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.
    Intervention: Other: Patient Directed Standard of Care
  • No Intervention: Enhanced Standard of Care
    Patients receive standard counseling from a genetic counselor.
Publications * Kaphingst KA, Kohlmann W, Chambers RL, Goodman MS, Bradshaw R, Chan PA, Chavez-Yenter D, Colonna SV, Espinel WF, Everett JN, Gammon A, Goldberg ER, Gonzalez J, Hagerty KJ, Hess R, Kehoe K, Kessler C, Kimball KE, Loomis S, Martinez TR, Monahan R, Schiffman JD, Temares D, Tobik K, Wetter DW, Mann DM, Kawamoto K, Del Fiol G, Buys SS, Ginsburg O; BRIDGE research team. Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial. BMC Health Serv Res. 2021 Jun 2;21(1):542. doi: 10.1186/s12913-021-06489-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
1980
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Speaks English

AND

  • First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer

OR

  • First degree relative or second degree relative diagnosed with the following <50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.

OR

  • Three of more relatives on the same side of the family diagnosed with the following clusters of cancer regardless of age:

    • Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
    • Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas Cancer, Urinary tract, Brain, Small intestine
    • Melanoma, Pancreas Cancer

OR

  • Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.

Exclusion Criteria:

  • Patients with a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing related to hereditary cancer.
  • Patients unable to access the patient portal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985852
Other Study ID Numbers  ICMJE IRB_00115509
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberly Kaphingst, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE New York University
Investigators  ICMJE
Principal Investigator: Kimberly Kaphingst, PhD University of Utah
PRS Account University of Utah
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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